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Efficacy studies in natural family planning: issues and management implications illustrated with data from five studies.

Studies of method effectiveness must be carefully assessed for comparability of findings. Several parameters are identified that are important in the assurance of comparable results. This article discusses these issues with the use of data from previously published studies and emphasizes the management implications of use-effectiveness data.

Data Interpretation, Statistical↗

Identifying the fertile phase of the human menstrual cycle.

The identification of the human fertile phase as the time during which a woman or a couple may conceive is elusive. The fertile time depends on many factors in each individual menstrual cycle and may be said to be more of a statistical than a physiological entity. This paper reviews the application of statistical methods to three areas related to conception and the fertile phase. The first is the prediction and detection of ovulation from serial measurements, such as hormones, basal body temperature and cervical mucus, throughout the menstrual cycle. Typically, such variables increase from some baseline level to a peak around ovulation (the most fertile time), then subside to low levels in the postovulatory phase. The statistical challenge is to detect the rise (signalling the onset of potential fertility) and subsequent fall. Analytic methods considered include thresholds, Bayesian change-point models and particularly the cumulative sum (cusum) technique which is both simple to apply and understand, and effective. The second area comprises appropriate methods of analysing and interpreting data from clinical studies of the fertile phase, especially in so-called natural family planning (NFP) where it is usual for women to observe several indices of potential fertility. Such studies usually try to establish the temporal relationships between markers of the fertile phase and examine the success of different combinations of markers in delineating the fertile time in comparison with a standard 'defined' phase, for example, the interval from three days before to two days after the peak of luteinizing hormone. The third area is the assessment of the probability of conception on certain days of the cycle, which is vital to the understanding of the fertile phase and its application to NFP. Direct estimation of such probabilities is impractical; instead, resort must be made to estimation by maximum likelihood of the parameters of specially constructed models. Suitable models are described. Finally, the need for a new prospective study of the probability of conception in relation to the markers of the fertile phase used in the symptothermal method of NFP is discussed.

Female↗

Human cervical mucus: research update.

Evaluation of cervical mucus is a standard for determining the fertile period in natural family planning. Cervical mucus accepts, filters, prepares, and releases sperm for successful transport to the egg and fertilization. Recent scientific advances provide answers to how the mucus regulates fertility as its physical properties change during the menstrual cycle. Transmission electron microscopy reveals small interstices between mucus macromolecules relative to a sperm head. Thus advancing sperm must push aside or cut through the microstructure. The interstices are largest in the periovulatory phase of the cycle. Small magnetic spheres, comparable with the size of a sperm head, are now being used to study the physical properties of the mucus on the scale of individual sperm.

Cervix Mucus↗

A prototype for ovulation detection: pros and cons.

A noninstrumented enzyme immunoassay for urinary estrone conjugates was adapted from an instrumented microtiter plate enzyme immunoassay assay. The end point of the assay was a color change from green to clear, which was visible to the unaided eye. The visible color change was adjusted to allow 80 ng/ml estrone conjugates (on the basis of a sample size of 6.5 microliters urine) to be distinguished from an infinite dilution without instrumentation. The evaluation of human urine collected from ovulatory ovarian cycles demonstrated that early follicular phase concentrations (35.9 +/- 6.8 to 79.4 +/- 14.7 ng/ml, n = 10) produced a dark-green color, whereas late follicular phase concentrations (162.9 +/- 20.1 ng/ml, n = 10) produced no color. Daily urine samples throughout 10 ovulatory ovarian cycles produced parallel profiles when compared to measurements of estradiol in paired blood samples. Complete analysis of the data indicated that ovarian follicular dynamics can be accurately monitored through the noninstrumented analysis of daily estrone conjugates in urine samples.

Adult↗

Characteristics of ovulation method acceptors: a cross-cultural assessment.

Five programs of instruction in the ovulation method (OM) in diverse geographic and cultural settings are described, and characteristics of approximately 200 consecutive OM acceptors in each program are examined. Major findings include: the religious background and family size of acceptors are variable, as is the level of previous contraceptive use. Acceptors are drawn from a wide range of socioeconomic and religious backgrounds; however, family planning intention was similarly distributed in all five countries. In sum, the ovulation method is accepted by persons from a variety of backgrounds within and between cultural setting.

Adult↗

[Male contraception].

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Contraceptive Agents, Male↗

Using complete breastfeeding and lactational amenorrhoea as birth spacing methods.

The aim of this study was to evaluate the effectiveness of lactational amenorrhoea and to determine the relationship between extended breastfeeding and the return of fertility. Breastfeeding pattern, basal body temperature, cervical mucus, salivary ferning, vaginal blood discharge, frequency of sexual intercourse, and the presence of ovulation in the first cycle after the resumption of menses with ultrasonography were evaluated in 40 women. All subjects completed the study with only one case of incomplete breastfeeding. No pregnancies were observed. The mean number of feeding sessions and mean interval between sessions decreased significantly (p <0.01) during the first six months postpartum (7.5 +/- 1.3 after 60 days postpartum vs. 5.7 +/- 2.1 after 180 days, and 3.6 +/- 0.8 vs. 5.1 +/- 0.9, respectively). Eight women (20%) menstruated before weaning, but none had an adequate thermal shift, while 32 (80%) had their first vaginal bleeding after weaning with 12 (37.5%) registering an adequate thermal shift. Both basal body temperature and salivary ferning proved to be suggestive of ovarian activity, while mucus characteristics were not reliable in identifying fertile periods. Our study showed that breastfeeding associated with lactational amenorrhoea proved to be a good method of postpartum fertility control. Since the importance of supplementation is still debated, it is recommended that a "complete" breastfeeding program be used.

Adult↗

Barrier contraception in the teenager: a comparison of four methods in adolescent girls.

The use-effectiveness and continuation rates of 4 methods of contraception were studied during a 2 year follow-up period in a group of 405 teenage girls. Results were compared in 2 groups of adolescents, 1 of highly motivated, high socioeconomic status girls (A) and 1 of poorly motivated, low socioeconomic status adolescent clinic patients (B). The method of contraception was selected by the girls, who were instructed in their proper use. Results showed good rates of continuation among girls of the 1st group as compared to those of the 2nd group. Pregnancy rates after 24 months of use, as calculated by Pearl's formula, was 3.6 and 5.4 respectively with the use of a condom, and 5.8 and 10.8 when the diaphragm was used. When using vaginal foam alone, the rates were 4.2 and 12.3 and with the rhythm method, 8.5 and 13.1. The foam-alone method was unpopular in both groups. No serious side effects or complications were recorded. The study demostrated a reasonable acceptability and use-effectiveness for barrier contraceptives. It is suggested that these harmless and complication-free methods, especially the condom and diaphragm, may be reasonable alternatives for the more modern methods in teens of all socioeconomic strata; an effort must be made to educate and instruct the poorly motivated and encourage them to present themselves for regular follow-up.

Adolescent↗